title: Establishment of an equivalence acceptance criterion for accelerated stability studies.
abstract: In this article, the use of statistical equivalence testing for providing evidence of process comparability in an accelerated stability study is advocated over the use of a test of differences. The objective of such a study is to demonstrate comparability by showing that the stability profiles under nonrecommended storage conditions of two processes are equivalent. Because it is difficult at accelerated conditions to find a direct link to product specifications, and hence product safety and efficacy, an equivalence acceptance criterion is proposed that is based on the statistical concept of effect size. As with all statistical tests of equivalence, it is important to collect input from appropriate subject-matter experts when defining the acceptance criterion.
authors.affiliation: Amgen, Inc., Longmont, CO 80503, USA. rburdick@amgen.com
authors.forename: Richard K
authors.initials: RK
authors.lastname: Burdick
authors.forename: Leslie
authors.initials: L
authors.lastname: Sidor
mesh_terms: D001702:Biopharmaceutics / Q000592:standards* / Q000706:statistics & numerical data*; D003198:Computer Simulation; D004355:Drug Stability; D004356:Drug Storage / Q000592:standards / Q000706:statistics & numerical data; D015233:Models, Statistical; D012107:Research Design / Q000706:statistics & numerical data; D013810:Therapeutic Equivalency; D013997:Time Factors